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Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03825380
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

Brief Summary:
The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Glaucoma Drug: Bimatoprost Drug: Lumigan® Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Assessment of T4032 Versus Lumigan® in Ocular Hypertensive or Glaucomatous Patients
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: T4032 Drug: Bimatoprost
Eyedrops

Active Comparator: Lumigan® Drug: Lumigan®
Eyedrops




Primary Outcome Measures :
  1. Intra-Ocular Pressure [ Time Frame: Week 12 ]
    Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent signed and dated.
  • Both eyes with diagnosed open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • History of trauma, infection, clinically significant inflammation within the 3 previous months.
  • Uncontrolled diabetic patient.
  • Pregnancy or breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825380


Contacts
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Contact: Medical Director +33473982081 Violaine.DESORTHENIN@theapharma.com

Locations
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Estonia
Hospital Recruiting
Tallinn, Estonia
Contact: Medical Director         
Sponsors and Collaborators
Laboratoires Thea
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Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT03825380    
Other Study ID Numbers: LT4032--301
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ocular Hypertension
Eye Diseases
Bimatoprost
Antihypertensive Agents